Testosterone sales have grown rapidly over the last decade, but few studies have examined the long-term effects of taking testosterone on cardiovascular health and other important outcomes. This week, investigators from Brigham and Women's Hospital (BWH) report the results of the Testosterone's Effects on Atherosclerosis Progression in Aging Men (TEAAM) trial in the Journal of the American Medical Association (JAMA). The three-year study finds that testosterone administration had no effect on the progression of hardening of the arteries in older men with low to low normal testosterone levels and did not significantly improve sexual function or health-related quality of life.
"The results of this trial suggest that testosterone should not be used indiscriminately by men," said corresponding author Shalender Bhasin, MD, director of BWH's Research Program in Men's Health: Aging and Metabolism and director of the Boston Claude D. Pepper Older Americans Independence Center at BWH. "We find that men with low and low normal testosterone are unlikely to derive benefits in terms of sexual function or quality of life, two reasons why men may seek testosterone therapy. And although we find that testosterone did not affect the rate of hardening of the arteries, we need long-term data from large trials to determine testosterone's effects on other major cardiovascular events."
Testosterone, a hormone primarily secreted by the testicles, plays a key role not only in male reproductive tissues but also in muscle growth, bone mass and body hair. As men get older, their testosterone levels naturally decline - on average by 1 percent a year after age 40. Previous studies that have aimed to examine rates of cardiovascular events in men taking testosterone have reported conflicting results but have raised concerns that testosterone therapy might increase a person's risk of a heart attack or stroke. Atherosclerosis, or the buildup of plaque in the arteries, is a critical risk factor for such cardiovascular events.
In the three-year, double-blind TEAAM trial, the research team enrolled more than 300 men over the age of 60 with total testosterone levels between 100-400 ng/dL (low to low normal range) and measured two indicators of atherosclerosis: calcium deposits in the arteries of the heart (coronary artery calcification) and the thickness of inner lining of the carotid arteries that supply blood to the brain (common carotid artery intima-media thickness). To measure secondary outcomes of sexual function and health-related quality of life, the research team had participants also completed a 15-item questionnaire. Participants applied a testosterone or placebo gel daily for three years.
"Our study has important implications for clinical practice, and for older men who are seeking testosterone therapy," said Bhasin. "Many men, as they get older, experience a decline in testosterone and in sexual function and vitality. But our study finds that taking testosterone, when levels are in the low to low normal range, may not improve sexual function or quality of life."
The TEAAM trial was designed to examine atherosclerosis progression and not cardiovascular events -- further studies will be needed to determine the cardiovascular safety of testosterone use in older men. The research team also notes that comparing patients using statins to those who are not could be another important direction for future studies.
This work was supported by Solvay Pharmaceuticals, Inc. Abbvie Pharmaceuticals, Inc., the Aurora Foundation, the Boston Claude D. Pepper Older Americans Independence Center grant 5P30AG031679, and the Boston University's Clinical and Translational Science Institute grant 1UL1RR025771. Testosterone and placebo gel for the study were provided by Solvay Pharmaceuticals, Inc., and later by Abbvie Pharmaceuticals.
Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 4.2 million annual patient visits, nearly 46,000 inpatient stays and employs nearly 16,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Brigham Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 1,000 physician-investigators and renowned biomedical scientists and faculty supported by nearly $600 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH continually pushes the boundaries of medicine, including building on its legacy in transplantation by performing a partial face transplant in 2009 and the nation's first full face transplant in 2011. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative as well as the TIMI Study Group, one of the premier cardiovascular clinical trials groups. For more information, resources and to follow us on social media, please visit BWH's online newsroom.